FDA applicant
Hana Biologics, Inc.
FDA records 8 decisions for Hana Biologics, Inc. (Walker, MI) from 1981 to 1988: 8 510(k) clearances. Most are in product codes JSI (Culture Media, Selective And Differential) and KIT (Media And Components, Synthetic Cell And…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hana Biologics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hana Biologics, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hana Biologics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report